- Dana-Farber Cancer Institute (Boston, MA)
- …regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulation and ... amazing partners, including other Harvard Medical School-affiliated hospitals. **Regulatory Compliance ** + Prepares and submits all protocol applications, amendments,… more
- Tecomet (Woburn, MA)
- …and communicate the training initiatives and document control and records to ensure compliance to FDA , Global Regulatory bodies and ISO requirements. Training ... **TITLE** : Document Control Coordinator **JOB SUMMARY:** Responsible for leading a structured,...organization, maintenance and storage of all documents related to FDA /ISO compliance , DMRs, DHRs, DCNs, and Management… more
- Beth Israel Lahey Health (Boston, MA)
- …a difference in people's lives.** The Sr. Regulatory Specialist supports regulatory compliance for clinical research at Beth Israel Deaconess Medical Center (BIDMC). ... deviations and submission of other study documents to support regulatory compliance . Troubleshoot processes and procedures when issues are identified. (essential) +… more
- Charles River Laboratories (Wilmington, MA)
- …a career that you can feel passionate about. **Job Summary** The Coordinator , Global Strategic Resources oversees the creation and management of purchase orders ... Safety Assessment sites and to coordinate purchases from third-party suppliers. The Coordinator also partners with the Strategic Resources Logistics team to ensure… more
- Beth Israel Lahey Health (Boston, MA)
- …of patients for participation in multiple clinical trials, ensuring compliance with federal, state and institutional guidelines. Financial responsibilities including ... of adverse events and reports them according to the guidelines of the FDA , sponsoring drug accompany (if applicable) and the IRB. May interact with sponsors… more
- Dana-Farber Cancer Institute (Boston, MA)
- …an ability to learn and work within multiple sets of regulatory compliance requirements, and performing complex decision tree procedures in more advanced levels ... is performed within standards as established by FACT, the FDA , NMDP, and JC, and the specific protocol under...them in accessing appropriate staff and resources to ensure compliance and support the best possible outcomes. **This is… more
- Takeda Pharmaceuticals (Boston, MA)
- …at Takeda + CMRP Meeting Chair - pausing to communicate comments to coordinator , diffusing team disputes, serving as a dependable negotiator, keeping team focus on ... lifecycle + Subject matter expert on EFPIA, IFPMA, and FDA code/regs, guidance, industry standards, complaints/violations, and innovative promotional platforms… more
- Boston University (Boston, MA)
- …of IRB-approved research studies to ensure that research is conducted in compliance with applicable regulations, policies, and guidance. These include both for-cause ... within human subject's research in positions such as IRB staff/analyst, study coordinator , or monitor/auditor is needed. + Experience in auditing not required but… more